Control device and analyzer

ABSTRACT

The present invention quickly resolves troubles in an analyzer and performs effective external quality control management. An analyzer ( 2 ) and a control device ( 1 ) are connected by a network ( 3 ). Error data and sample data taken from assay of a quality control substance are transmitted from the control device ( 1 ) to the analyzer ( 2 ). The analyzer ( 2 ) is made to be remotely operable from the control device ( 1 ) and when troubles arise repair from the control device ( 1 ) is possible. The control device ( 1 ) tallies sample data, and provides the tally results to a Web page. The analyzer ( 2 ) accesses the Web page using a WWW browser, and can perform external quality control in real time.

This application is a continuation of U.S. patent application Ser. No.11/105,560 filed on Apr. 14, 2005, which is a divisional of U.S. patentapplication Ser. No. 10/620,358 filed Jul. 17, 2003, now U.S. Pat. No.6,937,964, which is a divisional of U.S. patent application Ser. No.09/725,498 filed Nov. 30, 2000, now U.S. Pat. No. 6,629,060, whichclaims priority to Japanese Patent Application No. H11-341,085 filedNov. 30, 1999, the entire contents of all of which applications areincorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to technology for facilitating support ofanalyzers.

2. Description of the Related Arts

Blood tests and other forms of clinical examination require that samplessuch as blood and urine be analyzed for a variety of test items.Analyzers that employ assaying methods suited to the characteristics ofthe analysis items perform sample assays. Analyzers have sophisticatedmechanisms that allow them to assay, with a high degree of sensitivity,extremely low concentrations of a substance, and to assay trace amountsof sample for ten or more items. To maintain the accuracy of the testresults, operations in each of the mechanisms are monitored.

When problems arise in operation of the mechanisms, the analyzer issuesa warning to that effect, alerting the user to the problem in theanalyzer. In such cases, a user will deal with the problem by followingthe operating manual or, for example, by calling a support center,explaining the circumstances, and following the instructions of thetechnician. When the user cannot take care of it single-handedly, thesupport center dispatches a technician to do so.

Nevertheless, in clinical testing, merely monitoring the analyzermechanisms is insufficient for governing test results on vitalcomponents with satisfactory accuracy. Quality control is thereforeperformed. Samples identical with the vital components, or samples thatare their analogues, are assayed as quality control substances, and theassay results are monitored.

Both internal and external methods are utilized for quality control.Internal quality control is a method of assaying identical qualitycontrol substances daily with the same analyzer, and monitoring whetherstable assay results are being obtained. External quality control is amethod of monitoring whether assay results that are being obtained arethe same as results assayed by an identical analyzer employed outsidethose facilities.

In order to carry out external quality control, however, the samequality control substance has to be sent from a statistical tallyingcenter to each facility; the quality control substance has to be assayedat each facility; those assay results (“sample data” hereinafter) haveto be sent from each facility to the statistics center; and the sampledata has to be tallied by the statistics center. This means that thefacilities first learn of the external quality control results when thetally is sent back from the statistics center. From the time the qualitycontrol substance is sent out until the time the tally is returnedroutinely takes one to two months. Sometimes it is necessary to waituntil the statistics center accumulates a set number of sample datareturns.

A first issue the invention addresses relates to measures taken whentrouble has arisen. Because today's analyzers are operated under thecontrol of sophisticated programs, instances in which a user is unableto cope with the problem single-handedly are increasing. When such isthe case, the user has to wait until a technician visits to deal withthe problem.

The only option is to wait for the technician's visit if a systematicproblem can only be resolved by changing out or adjusting an analyzercomponent. Nevertheless, these are not the only reasons users cannotcope with breakdowns single-handedly. There appear to be many cases inwhich users ought to be able to resolve the trouble on their own. Insome instances, the trouble in the analyzer is not resolved because theuser cannot adequately explain the status of the problem; in others, theuser cannot properly carry out the analyzer operations necessary toresolve the trouble.

Because assay is not possible while an analyzer is down, patient testresults in clinical examination cannot be reported to the diagnosingphysician. For samples like blood, which has low preservation stability,delaying the assay by one day would mean lower accuracy in the testresults, and therefore blood has to be drawn from the patient again.

A second issue the invention addresses is that, with external qualitycontrol, as described above, confirmation can be obtained only bywaiting for the tally from the statistics center. This normally is doneonce a year, and at most on the order of only three or four times ayear.

To raise the reliability of assay data per se, quality control bydefinition should be carried out and the results checked before eachday's sample assays. In other words, if the quality control sample datafalls outside a predetermined range, this can mean that something hasgone wrong and that the analyzer is not in sufficient working order.Sample assay should be carried out following adjustment of the analyzerto bring the data within the predetermined range. With current externalquality control, however, the tally results come back one or two monthsafter assay, and are used for no more than confirming after-the-fact thestatus of the device at the time assay was made.

Wherein a substance such as blood that is liable to transform (denature)over time is the assay subject, the freshness of the quality controlsubstance employed in the sample data assay must be at the same levelamong each of the facilities taking part in external quality control.When quality control substances are sent out to facilities to collectsample data, inevitably the assaying tends to be performed on differentdays at different facilities. Accordingly, because the freshness of thequality control substances that are the basis for the sample datacollected tends to vary, the reliability of the tally results isdiminished.

SUMMARY OF THE INVENTION

It is an object of the present invention to enable rapid, exactresolution of analyzer problems and effective external quality control.

To address the foregoing first issue, an aspect of the present inventionpresents a support method employed in an information terminal connectedto analyzers via a network, the support method comprising: collectingfrom the analyzers via the network predetermined log informationindicating the operational history of the analyzers; storing thecollected log information for each analyzer; and outputting thecollected log information in response to instruction by the operator ofthe information terminal.

Communication between the information terminal and the analyzers isperformed through a dedicated telephone line (in Japan, for example, anNTT line), the Internet or the like. The operational history of eachanalyzer can be seen by support personnel at, for example, a supportcenter, and this can prevent analyzers from being down and canfacilitate repair work. Collecting log information by SMTP (Simple MailTransfer Protocol) has the advantage of allowing for easy expansion ofthe system over a network, since SMTP is usually not subject to therestrictions of firewalls and the like.

In this information-terminal employed support method, it is preferableto operate the analyzer from the information terminal via a network.

Support personnel can operate the analyzer while looking at the analyzeroperational history stored on the information terminal. When an analyzeris down, remote support personnel can quickly resolve the troublewithout having to travel to the actual site, leading to a significantreduction in down time.

Furthermore, good use can be made of a user support method wherein errordetermination parameters are prepared in advance; predetermined errorinformation is extracted from the log information; error histories arecreated by consulting (looking up) the error determination parameters;and error histories and the analyzer are correlatively stored.

For example, error level is determined based upon how many times thesame occurrence occurred in one day. Along with error type, errormessage, date and time, and other error log information, error levelsare correlated with analyzers and used in forecasting and solvingtrouble.

Further to address the first issue noted above, another aspect of thepresent invention presents a support method employed in an analyzerconnected to a predetermined information terminal via a network, whereinpredetermined log information showing the operational history of theanalyzer is transmitted at a predetermined timing to the informationterminal via the network.

For example, in the shutdown process for an analyzer the operationalhistory for that day is sent to the information terminal. Thepredetermined information terminal performs the same function as theinformation terminal in the above first aspect of the invention.

In the above support method used in an analyzer, it is preferable toaccept operations from a dedicated information terminal via the network.

Accepting control operations from an information terminal even when theinformation terminal is in a distant support center allows for the fastresolution of troubles.

To address the foregoing second issue, another aspect of the presentinvention presents a quality control method employed in an informationterminal connected to analyzers via a network, wherein:

A: sample data on assays made by the analyzers on predetermined qualitycontrol substances is received via a network;

B: the received sample data is stored;

C: the stored sample data is tallied for each analyzer and each qualitycontrol substance; and

D: the tally results for the received sample data are provided to theanalyzers within a predetermined timeframe.

Communication between the information terminal and the analyzers isperformed through a dedicated NTT line, the Internet or the like. Theanalyzers perform daily assay of quality control substances, such ascontrol blood, and transmit the assay data to the information terminal.The information terminal stores the assay data sent from analyzers andtallies the stored assay data for each analyzer and each quality controlsubstance. Each time the information terminal receives sample data froman analyzer it performs a new tally (statistical calculation).

In order that the tally results be on parameters in which the freshnessof the quality control substances is alike, the statistical calculations(tallying) may be on sample data assayed within a predeterminedtimeframe, for example, within twenty-four hours of being received. Whenan analyzer requests tally results, the latest tally results at thatpoint are provided in real time. In the present invention,communications by SMTP, which are unlikely to be subject to therestrictions of firewalls, are preferable.

To address the foregoing second issue, another aspect of the presentinvention presents a quality control method employed in analyzersconnected to a dedicated information terminal via a network, wherein:

A: sample data on assays made by the analyzers on predetermined qualitycontrol substances is transmitted to the information terminal via thenetwork;

B: tally results on the sample data are requested of the informationterminal;

C: the tally results on sample data the information terminal hascollected from the analyzers within a predetermined timeframe areacquired from the information terminal; and

D: the tally results are output.

Utilizing this method, the results that the information terminal in theabove information-terminal employed quality control method as talliedare output to an analyzer display, printer or other output device. Auser consults the output results to make an analyzer quality controlcheck on his or her own.

Another aspect of the present invention also presents acomputer-readable storage medium on which is recorded a program forexecuting the foregoing support method employed in an informationterminal or analyzer. Conceivable recording media include floppy disks,hard drives, semiconductor memory, CD-ROMS, DVDs, and MO disks.

Another aspect of the present invention also presents a control deviceconnected to analyzers via a network, comprising: reception means forreceiving from the analyzers via the network predetermined loginformation indicating the operational history of the analyzers; storagemeans for storing log information for each analyzer; and output meansfor outputting log information in response to instruction by anoperator.

This has the same operational effect as the above support method used inan information terminal.

Another aspect of the present invention presents an analyzer connectedto a dedicated information terminal via a network, comprisingtransmission means for transmitting predetermined log informationshowing operational history of the analyzer at a predetermined timing tothe information terminal via the network.

This has the same operational effect as the above support method used inan analyzer.

Another aspect of the present invention also presents a control deviceconnected to analyzers via a network, comprising: reception means forreceiving via the network sample data on assays made by the analyzers onpredetermined quality control substances; storage means for storingreceived sample data; statistical tallying means for tallying the storedsample data for each analyzer and each quality control substance; andprovision means for providing the tally results for the received sampledata to the analyzers within a predetermined timeframe.

This has the same operational effect as the above support method used inan information terminal.

Another aspect of the present invention also presents an analyzerconnected to a dedicated information terminal via a network, comprising:transmission means for transmitting to the information terminal via thenetwork sample data on assays made by the analyzers on predeterminedquality control substances; request means for requesting of theinformation terminal tally results on the sample data; acquisition meansfor acquiring from the information terminal the tally results on sampledata the information terminal has collected from the analyzers within apredetermined timeframe; and output means for outputting the acquiredtally results.

This has the same operational effect as the above support method used inan analyzer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an overall configurational diagram of a remote support systemin one example relating to the first embodiment;

FIG. 2 is a block diagram indicating functional configuration;

FIG. 3 is one example of process flow in the remote support system;

FIG. 4 is a flowchart showing one example of flow in a main processperformed by a control device;

FIG. 5 is a flowchart showing one example of support process flowperformed by the control device;

FIG. 6 is a flowchart showing one example of QC process flow performedby the control device;

FIG. 7 is a flowchart showing one example of flow in a main processperformed by an analyzer;

FIG. 8 is an example of an error information selection screen;

FIG. 9 is an error log display example;

FIG. 10 is a program log display example;

FIG. 11 is an operation count display example;

FIG. 12 is an example of error determination patterns;

FIG. 13 is an example of an error determination table;

FIG. 14 is a Web page display example (menu screen) created by a QCprocess;

FIGS. 15 and 16 are Web page display examples (tally results) created bythe QC process;

FIGS. 17 and 18 are overall configurational examples of a remote supportsystem relating to another embodiment;

FIG. 19 is a conceptual configurational diagram of data sent from ananalyzer to a control device;

FIG. 20A is a conceptual explanatory diagram of tallying process whereindata from the past 24 hours are the tallying object, and FIG. 20B is aconceptual explanatory diagram of tallying process wherein data from thepast 48 hours are the tallying object;

FIG. 21A is conceptual explanatory diagram of a current-day's tallyingprocess, and FIG. 21B is conceptual diagram of the previous day'stallying process;

FIG. 22 is flowchart showing one example of flow in a collectionprocess;

FIG. 23 is flowchart showing one example of flow in a current-day'stallying process; and

FIG. 24 is flowchart showing one example of flow in the previous day'stallying process.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The support method and quality control method of the present inventionwill be explained in detail with reference to the figures.

First Embodiment Overview

This embodiment will be explained using as an example a remote supportsystem that is a realization of the methods of the present invention.This remote support system is constituted by an analyzer owned by alaboratory (i.e., a user) and a control device of the party providingthe system, the devices being interconnected by a dedicated network.

The analyzer transmits predetermined log information according to apredetermined timing to the control device over the network contained inthe log information are operational information showing the operationalconditions of the analyzer and sample data. The operational informationcomprises error information, number of times operated, operationprogram, set-up parameters and the like for each analyzer. The sampledata is assay data from a quality control substance.

The control device performs a support process, collecting loginformation from each analyzer, editing the log information for eachanalyzer according to content, and storing the information, and performsa Quality control (QC) process.

A. Support Process

The control device edits operational information from collected loginformation and stores that information. The control device alsoanalyzes error content based on operational information, and if there isa significant error it displays that error. Because a technician canreview at the control device the log information of the analyzer wherethe error arose, he can sufficiently understand the conditions of themachine without needing a detailed explanation from the user, and canwork on finding the cause of the trouble.

In addition, the analyzer is provided with the capability to remotelyoperate the analyzer. Therefore, a technician does not actually have togo to the laboratory, but can work on the analyzer directly from thecontrol device. Furthermore, the control device can analyze errorinformation, predict when an analyzer will have trouble, and takemeasures to prevent trouble before it occurs.

B. QC Process

A control device litanies, i.e., makes statistical computations on,sample data from a quality control substance assayed at each analyzer 2per type of analyzer 2 and per type of quality control substance. Eachtime the control device 1 receives sample data, it updates the tallyresults for the same type of sample data at the same type of machines,and provides the latest tally results on a Web page. By accessing thisWeb page, the analyzer 2 can acquire the latest tally results. When ananalyzer attempts to access the Web page, the control deviceauthenticates the authentication information input by the analyzer. Inthis manner, soon after assaying a quality control substance, a user canconfirm in real time the very latest tally results for the qualitycontrol substance.

Configuration

(1) Overall Configuration

FIG. 1 is one example of an overall block diagram of a remote supportsystem according to the first embodiment. In the remote support systemaccording to this embodiment, the control device 1 and the analyzers 2are interconnected over a dedicated network 3.

The analyzer 2 is interconnected with the dedicated network 3 via anetwork communications interface 4. Possible analyzers includehemanalysis and urinalysis devices. Personal computers, workstations andthe like can be used as the control device 1. Dial-up routers and modemscan be used as the network communications interface 4.

One example that could be given of a dedicated network 3 would be adedicated telephone line that the provider of this system is able to useexclusively, through a contract with the company providing the telephoneline. Other types of networks than dedicated networks can be used, suchas the Internet and intranets and LANs.

(2) Control Device

FIG. 2 is a block diagram showing the functions and constitution of thecontrol device and the analyzer.

The control device comprises a communications interface 11, a processingunit 12, a user control database 14, an e-mail server 15, a WWW server16 and a remote control unit (host end) 13.

The communications interface 11 establishes a connection with analyzers.

The processing unit 12 performs support process and QC process, usingthe user control database 14. The support process displays predeterminederror log at the control device, making it possible to find the cause ofthe trouble. FIG. 8 through 11 show display examples of the error logoutput by the processing unit 12. These display examples are shown onthe display unit 17. The QC process makes possible real time externalquality control at the analyzer. FIGS. 14 and 15 show examples of Webpages for tally results created by the QC process. These examples willbe discussed in detail below.

The user control database 14 stores at each analyzer error log, numberof times operated, QC data, log information and the like.

The e-mail server 15 receives log information and sample data fromanalyzers through SMTP. The communications protocol is not limitedherein to SMTP, but SMTP has the advantage of facilitating futureexpansion of this system, due to the fact that it is usually not subjectto the restrictions of firewalls and the like.

The WWW server 16 provides a WWW browser on the analyzer with the Webpages that processing unit 12 has created.

The remote control unit (host end) 13, by being linked with the remotecontrol unit (user end) on the analyzer 2, makes possible the remoteoperation of the analyzer 2. Because the two units are inter-linked, theanalyzer can be logged onto remotely, the window displayed at theanalyzer is displayed at the remote control unit (host end) 13, and theanalyzer can be operated pursuant to the operations input from theremote control unit (host end) 13.

(3) Analyzer

An analyzer 2 has an analysis unit 21, and a user terminal 22, which hasa communications interface 23, an e-mail server 24, a remote controlunit (user end) 25, a WWW browser 26, a patient masking unit 27 and acontrol unit 28.

The analysis unit 21 assays the quality control substances and generatessample data.

The communications interface 23, as with the communications interface 11in the above control device 1, establishes a connection.

The e-mail server 24 sends log information showing the operationalhistory of an analysis unit 21 and sample data to the control deviceusing SMTP.

The remote control unit (user end) 25, by being inter-linked with theremote control unit (host end) 13, makes possible the operation of theanalyzer 2 from the control device 1.

The WWW browser 26 acquires Web pages from the control device based oninstructions from a user.

The patient masking unit 27 ensures that when the analyzer 2 is operatedfrom the control device 1, patient information is not displayed at thecontrol device.

The control unit 28 controls the operations of the analysis unit 21 andof the constituent elements of the user terminal 22.

Process Flow

An explanation will be given of the process performed by the controldevice and analyzer in a remote support system.

(1) Overall System Process Flow

An explanation will be made in detail of the process flow of the overallsystem. FIG. 3 is an explanatory diagram showing an example of the flowof user support in a remote support system.

The analyzer 2 performs routine sample assay (#1), and its operationalinformation is transmitted to the control device 1 according to apredetermined timing (#3). The transmission is made in real time if theoperational information contains error information or other urgentinformation. The transmission is made when the analyzer is shutdown ifthe operational information is not urgent, such as number of timesoperated and sample assay results. Error information is also displayedat the analyzer 2, too, and the user discovers that there is trouble atthe analyzer 2 (#8).

The control device 1 classifies operational information sent from theanalyzer 2 according to type and stores this in the user database 14(#4). When there is major error information in the stored operationalinformation, or when there are other indications that a predeterminedmajor error will occur, such as when there is minor error information,but the error occurs frequently or when error conditions are worsening,the trouble the analyzer is having is detected based on certain settings(#7).

When the analyzer 2 assays a quality control substance, unlike routinesample assay results, the sample data is transmitted to the controldevice 1 in real time (#3). The analyzer 2 reads a barcode affixed tothe assay sample container, determines whether that sample is a qualitycontrol substance or not, and based on that determination, transmits thesample data. The control device 1 takes the new sample data and updatesthe tally results (#5).

The user, after sample data assay, acquires the tally results that thecontrol device 1 has tallied (#6) and confirms the external accuracy.The control device 1 updates the Web pages in accordance with updates tothe tallied data. The analyzer 2 accesses a Web page, and when theaccess is authorized, the latest tally results and the sample data areprovided on the Web page.

In this manner, a user can quickly confirm not just internal qualitycontrol results, but external quality control results as well, and candiscover malfunctions in an analyzer in real time (#8).

The control device 1 tallies quality control data. If the qualitycontrol results fall outside of a predetermined range, or if a worseningof the quality control data is anticipated, trouble in the analyzer 2 isdetected based on predetermined settings (#7). For example, data istrending away from median values. If trouble at the analyzer 2 isdetected at the control device 1, the user is notified to that effect(#8).

If trouble at the analyzer is discovered (#8), the user carries outprocesses to resolve the trouble (#10). The control device 1 analyzesthe trouble from the edited operational information of that analyzer 2(#9), and provides the user with the most suitable information forsolving the trouble.

If it is difficult for the user to resolve the trouble himself, the useractivates the remote control unit of the analyzer (#11). A technician atthe support center remotely operates the analyzer 2 and performs taskfor resolution of the trouble via the remote control unit of the controldevice (#12). Thereupon the screen of the analyzer and the screen of thecontrol device are linked. In this manner, with regard to troubles thatcan be resolved through operation of the analyzer, even a complicatedproblem can be resolved through remote operation from the support center(#14). For troubles that cannot be resolved thus, a technician would goand make repairs (#13, #14).

(2) Control Device Process Flow

Next, the flow of a process that the control device 1 performs in aremote support system will be explained in detail.

(2-1) Collection Process

FIG. 4 is a flowchart showing one example of the flow of the mainprocess that the control device 1 performs. In the main process, thecontrol device 1 collects log information from the analyzer 2, and if itis operational history, stores it, and if it is sample data, performs QCprocess. The following process commences by means of the dial-up routerfrom the analyzer 2.

In Step S1, the communications interface 11 performs a connectionprocess to establish a connection with the analyzer 2.

In Step S2, the processing unit 12 performs a prescribed authenticationprocess. In other words, it determines whether the authenticationinformation sent from the analyzer 2 matches the user information in theuser database.

In Step S3, the processing unit 12 performs a process according to theauthentication results. If the determination is that the authenticationinformation matches, operation proceeds to Step S4. If it doesn't match,then the connection is cut or another like process is performed.

In Step S4, the e-mail server 15 receives data from the analyzer 2. Theprocessing unit 12 determines whether the received data is predeterminedoperational information or not. Operational information is predeterminedinformation other than sample data, and includes, for example, errordata, number of times operated, program log, and set-up information. Ifthe answer is “yes,” then Step S5 ensues; if “no,” Step S7 ensues.

In Step S5, the processing unit 12 temporarily saves the receivedoperational information. This is for use in the support process, whichis discussed below. In the support process, for example, operationalinformation from each analyzer 2 until 00:00 midnight, when the datechanges, is stored; when the time reaches 00:00, operational history iscreated based on the operational information received that day.

In Step S6, communications interface 11 severs the connection with theanalyzer 2.

In Step S7, the processing unit 12 determines whether the received datais sample data from assay of a quality control substance. If thedetermination is “yes,” then Step S8 ensues, proceeding to the QCprocess, which is discussed below. In other words, sample data,including received data, is tallied, and the Web page for each analyzeris updated. If the answer is “no,” the above-described Step S6 ensues,and the connection is severed.

(2-2) Support Process

FIG. 5 is a flowchart showing one example of flow in a support processthat the control device 1 performs independently of the main process.Every time the date changes, the control device 1 edits the operationalinformation received that day and writes that to the history database.

In Step S21, the processing unit 12 is waiting for a predetermined time,for example, 00:00.

In Step S22, the processing unit 12 determines which analyzer 2 amongthose registered in the user control database 14 is the subject user.

In Step S23, the processing unit 12 determines whether it has receivedoperational information showing operating conditions for that date forthe subject user. If the determination is “yes,” Step S24 ensues. If thedetermination is “no,” then Step S25 ensues.

In Step S24, the processing unit 12 edits operational information foreach analyzer and each subject matter, and writes this to the historydatabase. For example, it edits error information, number of timesoperated, operation program, and setting parameters, in separate tableformat with date and time, and writes this to the history database.

In Step S25, the processing unit 12 writes to the user control database14 predetermined error information showing that operational informationcould not be acquired. Possible examples of error information includeanalyzer name, date, time, error number showing the error that arose,and error message corresponding to error number.

In Step S26, the processing unit 12 searches for a predetermined errorbased on the error information of the subject user. For example, usingthe methods for determination shown in FIG. 12, error levels aredecided, as in the example shown in FIG. 13, from error type and thefrequency with which the same type of error occurs.

In Step S27, the processing unit 12 uses the search results to determinewhether or not errors are contained in the operational information ofthe subject user. Unless the error level is “0”, the determination is“Yes.” If the determination is “Yes,” Step S28 ensues; if “No,”later-described Step S29 ensues.

In Step S28, the processing unit 12 writes the determined error level tothe user control database 14.

In Step S29, the processing unit 12 determines whether Step S23 throughStep S28 have been performed for all registered analyzers 2. If “Yes,”operations return to Step S21, and wait for the date to change. If “No,”then operations return to Step S22, and choose another analyzer as thesubject user.

(2-3) QC Process

FIG. 6 is a flowchart showing the flow of the QC process the controldevice 1 performs. In the above-discussed main process, when the controldevice 1 receives sample data from any analyzer 2, the control device 1performs the following QC process. In other words, it tallies sampledata including newly received sample data, and updates the Web page foreach analyzer using the new tally results.

In Step S31, the processing unit 12 tallies sample data in which newlyreceived sample data is included. Multiple varieties of quality controlsubstances, such as those whose value is high and those whose value islow, and those whose value is within a normal range and those whosevalue is within an abnormal range, are often employed in the same assaycategory. Wherein the quality control substance is from vitalcomponents, values from lot to lot—that is, the lot number for eachmanufacturing instance—will routinely differ. Furthermore, assaying modeunder which the sample data was assayed must be taken into considerationin order to determine correction values for the assayed data. Thecontrol substance type, lot number, and assaying mode are reported fromthe analyzer to the control device in a manner to be described later.

Statistical tallying is conducted for each sort of analyzer and for eachkind of quality control substance. Because substances like blood, whichare liable to change (denature in the case of blood) over time, are usedas the quality control substance, tallies are made each assay day toraise the reliability of the tally results. That the latest tallyresults are presented in real time in the present invention engendersthe risk that the reliability of the tally results is not kept up duringthe early morning hours since the total count of sample data for thatday's assays is insufficient. Therefore, the tally for that day's assaysis made on sample data received, for example, within the past 24 hours.In this way, sample data from assaying conditions under the sameelapsed-time changes can be employed, which prevents the total countfrom fluctuating markedly according to time slot. At the point the datechanges, the tally results within the past 24 hours are set as the tallyresults for that day.

To improve the reliability of the tally results, it is preferable thatcutoff values of mean plus or minus 3 SD be used, and that values faroutside the normal range not be included in the analysis. When the tallyresults are presented in the form of the average value of the sampledata, and there is a very small amount of data for a 24-hour period, itwould be better to use median value in place of average value.

In Step S32, the processing unit 12 updates the Web page for eachanalyzer based on the new tally results. Then it returns to the mainprocess and severs the connection with the user terminal.

It should be noted that the timing for updating the tally results is notlimited to being based on the time sample data was received, as long asthe timing is such that the latest tally results can be presented to theanalyzer. For example, one conceivable alternative would be to updatethe tally results when a Web page has been accessed from an analyzer.Or, the tally results may be updated at a predetermined time intervalset in consideration of the load being placed on the analyzer.

(2-4) Other Processes

The control device 1 performs other processes in addition to mainprocess, support process and QC process.

For example, the WWW server 16 provides a Web page when the WWW browseron the analyzer has accessed the Web page. On this occasion, it ispreferable that the analyzer perform the authentication process in theform of an interface program, such as a library or CGI (Common GatewayInterface) scripts.

Also, the processing unit 12, in response to instructions from theoperator of the control device 1, displays error log stored in the usercontrol database 14.

(3) Analyzer Process Flow

FIG. 7 is a flowchart showing one example of the flow of the mainprocess performed by the analyzer. The analyzer 2 transmits errorinformation and sample data in real time, and transmits operationalinformation other than error information when the operations of theanalyzer's end. FIG. 7 shows only the flow according to the presentinvention. When the analyzer is activated, the following processcommences.

In Step S41, the control unit 28 monitors the operational conditions ofthe analysis unit 21 and determines whether error information hasoccurred or not. If the determination is “Yes,” then Step S42 ensues. If“No,” then Step S44, explained later, ensues.

In Step S42, the control unit 28 acquires error information from theanalysis unit 21 and processes it to be data for email. For example, itcreates email in which analyzer authentication information and errorinformation is written into the main body of the text.

In Step S43, the control unit 28 activates the e-mail server 24 andtransmits the created email. Then operations return to Step S41.

In Step S44, the control unit 28 determines whether sample data is to becollected. If the determination is “Yes,” then Step S45 ensues. If “No,”later-explained Step S48 ensues.

In Step S45, the control unit 28 stands by for termination of the assay.Upon completion Step S46 ensues.

In Step S46, the control unit 28 acquires sample data from the analysisunit 21 and processes it to be data for email. For example, it writesauthentication information into the text of the email, and creates anemail with the sample data attached as a file attachment. Otherinformation that is needed when analyzing sample data may be included inthe file attachment. Such information includes, for example, lot number,type of quality control substance, assay mode, and device ID. Device IDis identification information for the purpose of identifying an analyzeron this system, and is used to prevent sample data from being enteredmore than once during analysis.

In Step S47, the control unit 28 activates the e-mail server 24 andtransmits the created email.

In Step S48, the control unit 28 awaits for operational informationshowing the operational conditions of the analysis unit 21 other thanerror information. Operational information other than error informationcan include number of times operated, operation program, set-upconditions and the like. When operational information arises, operationsproceed to Step S49. In all other cases, the process flow proceeds toStep S50.

In Step S49, the control unit 28 saves in a log the operationalinformation that has arisen.

In Step S50, the control unit 28 determines whether instructions havebeen given for completion of the analyzer. If the determination is “No,”then the operations return to Step S41. If “Yes,” then Step S51,described later, ensues.

In Step S51, the control unit 28 acquires operational information fromthe log and processes this to be email data. For example, it createsemail in which analyzer authentication information and operationalinformation are written into the text of an email.

In Step S52, the control unit 28 activates the e-mail server 24 andtransmits the created email. After that, the control unit 28 terminatesoperations.

Specific Example of Operational Information Stored in History Databaseby Support Process

An explanation will be given in detail regarding the operationalinformation stored in the user control database 14 by the supportprocess described above. FIG. 8 through 11 show examples of operationalinformation displayed at the control device 1 when a hemanalyzer hasbeen used as the analyzer. FIG. 8 shows an example of an operationalinformation selection screen, FIG. 9 shows an example of error log, FIG.10 shows an example of program log, and FIG. 11 shows an example ofnumber of times operated.

The operational information selection screen of FIG. 8 acceptsselections for error log, program log, settings, or number of timesoperated. An operator can use this screen to designate analyzer and typeof analyzer.

FIG. 9 shows an example of a screen displayed when “error log” has beenselected on the operational information selection screen of FIG. 8.Error date and time, error message describing error, error codespecifying error, and detailed code 1 and detailed code 2 are displayed.This error log displays, for example, the latest month worth of errorlog stored in the history database. It is preferable that it be possibleto make settings for sorting and filtering for each field. It is alsopreferable that records of abnormalities that have a high possibility ofbeing the cause of trouble be displayed in an easily distinguishablereverse display or the like. Records of abnormalities, for example, arerecords of occurrences where the above-described error level is above apredetermined value.

FIG. 10 shows an example of a screen displayed when “program log” hasbeen selected on the screen of FIG. 8. In this example, the program nameof the program operated at the designated analyzer, the version thereof,and the time and date operated are displayed.

FIG. 11 shows an example of a screen displayed when “operation count”has been selected on the screen of FIG. 8. In this example, the numberof times that a predetermined unit of the analyzer has been operated isdisplayed along with the operation date and time.

Although not shown in the figures, when “settings” is selected on theselection screen of FIG. 8, the setting terms for the analyzer aredisplayed.

Specific Example of Web Page Created by QC Process

An explanation will be given of a specific example of a Web page createdby the control device 1 using the QC process described above. FIGS. 14and 15 show examples of Web pages created by the processing unit 12. Asbefore, these are examples of displays of tally results when analysesare made of a quality control substance using the hemanalyzer.

When a WWW browser on an analyzer accesses the control device 1, thewindow shown in the top half of FIG. 14 is displayed. This window allowsthe selection of a display style for the tally results. Here, an SDIchart has been selected as the “reporting style,” causing the windowshown in FIG. 15 to be displayed.

In FIG. 15, a predetermined graph is displayed for each blood component.This graph is created for each type of analyzer and each quality controlsubstance. This graph is capable of displaying the past month's dailysample data for the accessing user and reference machine data. Thereference machine data is sample data from assaying a predeterminedquality control substance taken at an analyzer of the provider of theremote support system. The graph also displays degree of deviation frommean value, 1 SD (1 standard deviation) by 1 SD. The daily tally resultsare finalized when the date changes.

In terms of internal quality control, displaying these assay values asthey are allows confirmation of the fluctuations in sample data from ananalyzer. In terms of external quality control, confirmation is possibleof the fluctuations in the sample data from an analyzer against theoverall average, using the overall average at the time of taking thesample data, as shown in FIG. 15. By changing the display as he seesfit, a user can make a visual comparison to see how much the sample dataof the analyzer deviates from the overall average and the referencemachine data. Furthermore, the Web pages on FIGS. 14 and 15 are updatedimmediately after sample data has been submitted. Therefore, a user canperform external quality control for the sample data he has submitted inreal time, without a time lag.

FIG. 16 is another display example of tally results for a qualitycontrol substance. In this example, the assay values for the user'sanalyzer, overall average value, and reference machine data aredisplayed individually. Because there are times when the user wants tomake direct comparisons between the assay values of his own analyzer andthe overall average and reference machine data, it is preferable to makeit possible to display individually the values in FIG. 15 that aredisplayed within a chart.

Other Embodiments

(A) FIGS. 17 and 18 are block diagrams showing other examples of theremote support system. The network linking the user terminal and theanalyzer does not necessarily have to be a dedicated network, but may bethe Internet or a LAN. However, when the Internet is used, encoding anda stricter authentication system need to be used to heighten securitywhen transmitting information.

It is not necessary for there to be just one control device on thesystem. For example, separate dedicated networks may be connected by theInternet and routers and gateways, and a control device may be providedfor each dedicated network. In addition, a control device can collectpredetermined information from analyzers of a dedicated network, forexample analyzers on the Internet connected via a dedicated network androuter, or analyzers connected to a LAN connected to the Internet via afirewall.

(B) In the above first embodiment, possible differences in times zonesbetween the control device 1 and the analyzers 2, and among analyzerswhen the QC process is conducted are not taken into consideration.Therefore, as the second embodiment, an explanation will be given of theQC process in a remote support system having a control device andanalyzers in different times zones.

(B-1) System Operation

Analysis of sample data is conducted in the following way. In the samemanner as the first embodiment, data collected in the past 48 hours istallied, and those results become real time tally results.Alternatively, the tally results for each day are computed by tallyingfrom among the data collected in the past 48 hours, including datacollected during the previous day.

To make it easy for operators of analyzers in each time zone to confirmtally results, tally results are correlated with those time zones (i.e.,local time) and so inscribed.

However, when the reference time for analysis is set as local time, thereference time will differ from time zone to time zone, and thusanalyses have to be conducted for each time zone. This means that therewill be 24 different tally results across the world for a single date,making operation of the system complicated. On top of this, there arecountries that have more than one time zones, and group hospitals thatare located across more than one time zones.

On the other hand, when one of the time zones is the basis for theanalysis reference time, without regard to local time, the differentialbetween local time and reference time becomes a problem. For example,confusion will result if the date of the QC process changes in themiddle of the analysis of an analyzer.

For this reason, to ensure that the tally results for a given day arethe same for all time zones, the tally results for that day are computedwith sample data having the same assay date (local time) according toeach time zone.

(B-2) Base

In consideration of the above, in this embodiment, the reference timefor the control device 1 is made to be the world's most advanced time,namely, GMT (Greenwich Mean Time)+12 hours. In the explanation below,the reference for time of day is the time of day of the time zone inwhich the control device 1 is located, in this instance, the GMT+12hours time zone. Each analyzer 2 transmits to the control device 1,along with the sample data, the assay time and date in the time zone inwhich it is located. The control device 1 conducts analysis of thesample data based on sample data having an assay time and date withinthe past 48 hours. The reason for tallying sample data for the past 48hours rather than the past 24 hours is to ensure that there will be asufficient number of sample data sets N that will form the basis of theanalyses.

FIG. 19 is a conceptual diagram of data transmitted from the analyzer 2to the control device 1. Included in this data are lot number, type ofquality control substance, assay mode, device ID, time zone, time ofday, and sample data. Except for time zone and time of day, all otherdata is the same as in the first embodiment. For time zone, the timezone in which the analyzer 2 is located is given. For time of day, theassay date and time in the time zone in which each analyzer is locatedis given. The control device 1 conducts the QC process to be discussedlater based on sample data having assay date and time within 48 hours ofthe time of day in the time zone in which the control device is located.

FIG. 20A is an explanatory diagram showing there being an insufficientnumber of sample data sets N received in the past 24 hours. Tofacilitate the explanation, let us suppose that analyzers A, B, C, D,and E are located in different times, and transmit sample data daily atthe local time of 00:00 in each time zone. Analyzer A is in the GMT+12hours time zone. Analyzer E is in the GMT-12 hours time zone, andanalyzers B, C, and D are in time zones in between. The control deviceis in the GMT+12 hours time zone.

In FIG. 20, sample data with a date of X are indicated as A_(x), B_(x),etc. For example, A₁, A₂, and A₃ represent sample data from analyzer Adated the 1^(st), 2^(nd) and 3^(rd), respectively. Black circlesrepresent sample data that has already been collected, and white circlesrepresent sample data that has not yet been collected.

When the time for the control device is 00:00 on the 3^(rd) day (time ofday T1), A₂, B₂, C₂, D₂ and E₂ are included in the sample data from thepast 24 hours. However, when a little time passes and the time of daybecomes the time of day T2, all that is included in the sample data fromthe past 24 hours is the data in the shaded triangular region in thefigure, that is, only A₃. In such a case, the further a time zone isfrom GMT+12 hours, the greater the possibility that the sample data willnot be tallied, meaning that there will be an insufficient number ofdata sets N and that it will be difficult to always provide reliabletally results.

FIG. 20B is an explanatory diagram showing there being a sufficientnumber of data sets N when the analysis is based on sample data receivedin the past 48 hours. When the time for the control devices reaches00:00 on the 3^(rd) (time of day T1), sample data from analyzers Athrough E dated the 1_(st) and 2^(nd) (A₁, B₁, C₁, D₁, E₁; A₂, B₂, C₂,D₂, E₂) are included within the sample data from the past 48 hours.

Next, when a little time passes and the time of day becomes time of dayT2, the data within the shaded trapezoidal region in the figure (i.e.,A₂, B₂, C₂, D₂, and E₂) becomes the population for analysis. Inactuality, while the assay time differs for each analyzer, by making theanalysis population the sample data of the past 48 hours, it is possibleto ensure that there is always a number of sample data sets close to thetotal number of analyzers on the system. If there is a plurality ofsample data sets from the same analyzer within the population, all suchsets other than the sample data set with the most recent assay time maybe excluded from the analysis.

It should be noted that the reference time for the control device is notlimited to GMT+12 hours. It is also possible to make the period of timesubject to analysis longer than 48 hours or shorter than 48 hours;however, 48 hours is expedient in terms of system operations.

(B1-3) Process Flow

With the exception of the QC process sub-routine (Step S8 in FIG. 4)performed after receipt of sample data, the process performed by thecontrol device 1 relating to this embodiment is the same as with thefirst embodiment. A detailed explanation follows below of the QC processin this embodiment. The QC process of this embodiment is divided into(1) a current-day's tallying process and (2) the previous day's tallyingprocess.

(B-3-1) Conceptual Illustration of a Current-Day's Tallying Process

FIG. 21A is a drawing explaining the concept of a current-day's tallyingprocess. In the current-day's tallying process, first preliminarypopulation made up of sample data dated within the past 48 hours issequentially created, using the time at the control device 1 as thereference time. Furthermore, sample data analysis is conducted based onthe first preliminary population, and the current-day's tally resultsare updated. In this embodiment, the updating and tallying process ofthe first preliminary population is conducted every 10 minutes.

In FIG. 21( a-1), the shaded trapezoidal region S0 shows the firstpreliminary population at the current time of day T1 (18:00 on the2^(nd)). With the passage of time the trapezoidal region S0 progressesto the right in the figure. That is, the first preliminary population isupdated. As the first preliminary population is updated, the tallyresults for today (i.e., the 2^(nd)) are also updated.

At the point of time T2 (00:00 on the 3^(rd)) when the date changes fromthe 2^(nd) to the 3^(rd), the previous day's tallying process forfinalizing the tally results of the second is activated. In FIG.21A(a-2), the shaded trapezoidal region, i.e., the sum of region S1 andS2′, represents the first preliminary population at time of day T2.Region S1 represents the group of sample data sets dated the 1^(st) andregion S2′ represents the group of sample data sets dated the 2^(nd)that were obtained at this point in time.

Even if the previous day's tallying process has been activated, thecurrent-day's tallying process continues to be conducted in the samemanner as described above. The current-day's tallying process, as itcontinues, updates the tally results of today (i.e., the 3^(rd))according to a predetermined timing.

(B-3-2) Explanation of a Previous Day's Tallying Process

FIG. 21B explains a previous day's tallying process. When this processhas been activated at 00:00 on the 3^(rd), the control device 1 createsa second preliminary population. The control device 1 updates the secondpreliminary population every 10 minutes, and updates the tally resultsfor the previous day (i.e., the 2^(nd)) based on the updated secondpreliminary population.

The creation and update of the second preliminary population isconducted as follows. Every 10 minutes the control device 1 creates asecond preliminary population made up of sample data from the past 48hours. As the time of day progresses from T2 (00:00 on the 3^(rd)),sample data dated today (i.e., the 3^(rd)) that was collected inadvanced time zones is deleted from the created second preliminarypopulation.

FIG. 21( b-1) shows a second preliminary population at time of day T3(10:00 on the 3^(rd)), 10 hours into the day T2. Region S1′ is a groupof sample data dated the 1^(st) and having an assay time within 48 hoursof T3. Region S2′ is a group of sample data with an assay date of the2^(nd) that has already been collected. Region S3′ is sample data fromthe past 48 hours that is dated the 3^(rd) and is to be deleted from thesecond preliminary population. At time of day T3, the control devicecomputes the tally results for the previous day (the 2^(nd)) based onthe sample data from region S1′ and region S2′.

FIG. 21( b-2) is the second preliminary population at a point in time ofday T4 (00:00 on the 4^(th)), which is 24 hours after the time of dayT2. The shaded region S2 indicates the second preliminary population atthis point in time. The second preliminary population at this point intime comprises the group of sample data sets dated the 2^(nd) from allthe analyzers participating in the remote support system. At this pointin time, the control device 1 finalizes the population for the analysisof the day two days prior (the 2^(nd)). The tally results obtained fromthis population become the final tally results for the day two daysprior (the 2^(nd)).

(B-4) Flowchart

In this embodiment, the control device 1 conducts three types of QCprocess independently: a collection process, the current-day's tallyingprocess, and the previous day's tallying process.

(B-4-1) Collection Process

FIG. 22 is a sample data collection process that the control device 1performs. This process commences when Step S8 (QC process sub-routine)ensues in the main process executed by the control device 1 (FIG. 4). Inother words, in this embodiment, each time the control device 1 receivessample data, that data is stored in the base database (not shown infigure). The sample data that the control device 1 receives is stored inthis base database without any deletions.

(B-4-2) A Current-Day's Tallying Process

FIG. 23 is a flowchart showing the flow of the current-day's tallyingprocess performed by the control device 1. In the explanation below, abuffer 1 shall be the work area for forming the first preliminarypopulation that will serve as the basis for the current-day's tallyingprocess.

Steps S101, S102: The control device 1 determines whether the date haschanged (S101). If it has changed, it activates the previous day'sprocess (S102) (refer to FIG. 21( a-2).

Steps S103, S104, S105, S106: The control device 1 determines whether apredetermined time, i.e., 10 minutes, has elapsed since the previousanalysis (S103). If it hasn't elapsed, operations return to Step S101without analyses being made. If it has elapsed, the first preliminarypopulation is updated and the current-day's analysis is updated.

Specifically, sample data having a time and date within the past 48hours is first acquired from the base database and is held in the buffer1 (S104). Next, it is determined whether among the data held in thebuffer 1 there is more than one set of data from the same analyzer(S105). If there is, all such data except the most recent is excludedfrom the buffer 1 (S106) [refer to FIG. 21( a-1)].

Step S107: The control device 1 performs analyses based upon the updatedfirst preliminary population. These tally results will serve as thecurrent-day's tally results for this point in time.

The control device 1 performs the above process independently of thesample data collection process, and updates the current-day's tallyresults every 10 minutes, based on sample data from within the past 48hours.

(B-4-2) A Previous Day's Tallying Process

FIG. 24 is a flowchart showing the flow of the previous day's tallyingprocess that the control device 1 performs. In the explanation below, abuffer 2 shall be the work area for forming the second preliminarypopulation that will serve as the basis for the previous day's tallyingprocess. When operations in the above-described the current-day'stallying process proceeds to Step S102, the following process isactivated. As with FIG. 21 above, we will suppose that this processcommenced at time of day T2 (00:00 on the 3^(rd)).

Step S111: The control device 1 again determines whether the date haschanged; if it hasn't the process starting with Step S112 is performed.In other words, until the time of day changes from T3 (00:00 on the3^(rd)) to T4 (00:00 on the 4^(th)), the update of the secondpreliminary population and update of the analysis are conducted (S112 toS117, described below). When the time of day reaches 00:00 on the4^(th), the tally results of two days prior, that is, the 2^(nd), arefinalized (Steps 118 through 120 described below).

Step S112: The control device 1 determines whether 10 minutes haveelapsed since the previous analysis. If the determination is “Yes,” thenStep S113 ensues, and the second preliminary population is updated. Ifthe determination is “No,” it does not update the preliminary populationand operations return to Step S111.

Steps S113, S114, S115, S116: The control device 1 acquires from thebase database sample data from within the past 48 hours and holds thesein the buffer 2 (S113). Next, the control device 1 deletes data datedtoday (i.e., the 3^(rd)) from the acquired sample data (S114). Next, itis determined whether among the data held in the buffer 2 there is morethan one set of data from the same analyzer (S115). If there is, allsuch data except the most recent is excluded from the buffer 1 (S116).In this manner, the second preliminary population is updated [refer toFIG. 21( b-1)].

Step S117: The control device 1, based on the updated second preliminarypopulation, newly computes tally results for the previous day, namely,the 2 nd. In this manner the tally results for the 2^(nd) (the previousday) are updated every 10 minutes (S112 to S117).

Step S118: If it is determined at Step S111 that the date has changed,in other words, that the time of day has become 00:00 on the 4^(th), thecontrol device 1 finalizes the population that will serve as the basisfor the tally results of the 2^(nd). In other words, the secondpreliminary population at this point in time becomes the population forthe tally results of the day two days prior (i.e., the 2^(nd)). Onlysample data dated the 2^(nd) is contained in the finalized population[refer to FIG. 21( b-2)].

Steps S119: The control device 1 computes the tally results for the daytwo days prior based on the finalized population.

The display of the Web page on which the above tally results are postedis executed based on authentication information input from the analyzer.When a Web page is displayed, the control device 1 confirms: the timezone of the analyzer. The reason for this is that it is conceivable thatthe local time in that time zone is a date other the date in the GMT+12hours times zone, that is, it is not that date yet. In such cases, thecontrol device 1 does not display the current-day's tally results forthe GMT+12 hours time zone, but displays only the tally results of theprevious day's tallying process.

With the above-described process, based on sample data collected fromanalyzers located across the world, the current-day's tallying processsequentially updates the current-day's tally results and the previousday's process updates the previous day's tally results. In addition, thetally results for each day are finalized through the previous day'stallying process. Because the analysis is performed based on there beingat least a certain number of sample data sets, the reliability of thetally results can be improved. Furthermore, because sample data takenfrom assays in each time zone is reflected in that day's tally results,a user can use this system without being aware of any differences intime zones.

(C) Storage media on which is recorded the above-described programs ofthe present invention are included in the present invention. These mediacan include, among others, computer-readable floppy diskettes, harddisks, semiconductor memory, CD-ROMs, DVDs, and opto-magnetic disks.

(D) Media that transmit the programs of the present invention are alsoincluded in the present invention. These transmission media includetelecommunication media (optical fibers, wireless networks, inter alia)in computer network systems (LAN, Internet, wireless communicationnetwork) for transporting and supplying program information as carrier.

Through the use of the present invention, the history of an analyzer isstored in a control device, thus making possible rapid response totrouble arising in the analyzer and shortening the down time of theanalyzer. Also, the external control of an analyzer can be performedessentially in real time.

While only selected embodiments have been chosen to illustrate thepresent invention, to those skilled in the art it will be apparent fromthis disclosure that various changes and modifications can be madeherein without departing from the scope of the invention as defined inthe appended claims. Furthermore, the foregoing description of theembodiments according to the present invention is provided forillustration only, and not for the purpose of limiting the invention asdefined by the appended claims and their equivalents.

1. A terminal apparatus for external quality control comprising: areceiver configured to receive an assay result of a quality controlsample assayed by at least one analyzing instrument located in at leastone facility where the at least one analyzing instrument assays thequality control sample for external quality control and assay samplesfor clinical examination of patients; a control data processorconfigured to generate quality control data comprising the assay resultof the quality control sample attached with identification dataindicative of at least one of (i) an identification of the at least oneanalyzing instrument, (ii) a lot number of the quality control sample,(iii) an identification of a control type, and (iv) an identification ofan assay mode under which the quality control sample was assayed; acommunication control configured to upload the quality control data to acontrol center via a network discriminately from assay results of theassay samples; and a display control configured to display a report fromthe control center which statistically analyzes the assay result of thequality control sample assayed by the at least one analyzing instrumentagainst assay results of the quality control sample received by thecontrol center.
 2. A terminal apparatus according to claim 1, whereinbefore uploading the control data, the communication control establishesa communication path through an authentication process with the controlcenter.
 3. A terminal apparatus according to claim 1, further comprisingan Internet access control configured to access a website of the controlcenter.
 4. A terminal apparatus according to claim 3, wherein thedisplay control displays the report from the website of the controlcenter.
 5. A terminal apparatus according to claim 1, wherein the reportshows a deviation of the assay result of the quality control sampleassayed by the at least one analyzing instrument from an average of theassay results of the quality control sample received by the controlcenter.
 6. A terminal apparatus according to claim 1, wherein the assayresults of the quality control sample received by the control center arecollected from a plurality of analyzing instruments.
 7. A terminalapparatus according to claim 6, wherein the plurality of analyzinginstruments are located in different facilities.
 8. A terminal apparatusaccording to claim 1, wherein the communication control comprises ane-mail communication control.
 9. A method for external quality controlimplemented at a terminal apparatus, comprising: receiving an assayresult of a quality control sample assayed by at least one analyzinginstrument located in at least one facility where the at least oneanalyzing instrument assays the quality control sample for externalquality control and assay samples for clinical examination of patients;generating quality control data comprising the assay result of thequality control sample attached with identification data indicative ofat least one of (i) an identification of the at least one analyzinginstrument, (ii) an identification of the quality control sample, (iii)an identification of a controlled analyte contained in the qualitycontrol sample, and (iv) an assay mode under which the quality controlsample was assayed; discriminately from assay results of the assaysamples, uploading the control data to a control center via a network;and displaying a report from the control center which analyzes the assayresult of the quality control sample assayed by the at least oneanalyzing instrument against assay results of the quality control samplereceived by the control center.
 10. A method according to claim 9,wherein uploading the control data comprises establishing acommunication path through an authentication process with the controlcenter.
 11. A method according to claim 9, further comprising accessinga website of the control center.
 12. A method according to claim 11,wherein displaying a report comprises displaying the report from thewebsite of the control center.
 13. A method according to claim 9,wherein the report shows a deviation of the assay result of the qualitycontrol sample assayed by the at least one analyzing instrument from anaverage of the assay results of the quality control sample received bythe control center.
 14. A method according to claim 8, wherein the assayresults of the quality control sample received by the control center arecollected from a plurality of analyzing instruments.
 15. A methodaccording to claim 14, wherein the plurality of analyzing instrumentsare located in different facilities.
 16. A method according to claim 9,wherein uploading the control data comprises e-mailing the control data.17. A control apparatus for external quality control, comprising: areceiver configured to receive, from a user terminal via a network, anassay result of a quality control sample assayed by at least oneanalyzing instrument located in at least one facility where the at leastone analyzing instrument assays the quality control sample for externalquality control and assay samples for clinical examination of patients,wherein the receiver receives the assay result attached withidentification data indicative of at least one of (i) an identificationof the at least one analyzing instrument, (ii) an identification of thequality control sample, (iii) an identification of a controlled analytecontained in the quality control sample, and (iv) an assay mode underwhich the quality control sample was assayed; an average calculatorconfigured to calculate an average of received assay results of thequality control sample; a data analyzer configured to prepare a reportwhich analyzes the assay result of the quality sample assayed by the atleast one analyzing instrument against the average of the received assayresults; and a website manager configured to place the report on awebsite on an Internet.
 18. A control apparatus according to claim 17,wherein the report shows a deviation of the assay result of the qualitycontrol sample assayed by the at least one analyzing instrument from theaverage of the received assay results.
 19. A control apparatus accordingto claim 17, wherein the quality control sample is assayed by aplurality of analyzing instruments which are located in differentfacilities.
 20. A control method for external quality controlimplemented in a control apparatus, comprising: from a user terminal viaa network, receiving an assay result of a quality control sample assayedby at least one analyzing instrument located in at least one facilitywhere the at least one analyzing instrument assays the quality controlsample for external quality control and assay samples for clinicalexamination of patients, wherein the received assay result is attachedwith identification data indicative of at least one of (i) anidentification of the at least one analyzing instrument, (ii) anidentification of the quality control sample, (iii) an identification ofa controlled analyte contained in the quality control sample, and (iv)an assay mode under which the quality control sample was assayed;calculating an average of received assay results; preparing a reportwhich analyzes the assay result of the quality control sample assayed bythe at least one analyzing instrument against the average of thereceived assay results; and placing the report on a website on anInternet.
 21. A control method according to claim 20, wherein the reportshows a deviation of the assay result of the quality control sampleassayed by the at least one analyzing instrument from the average of thereceived assay results.
 22. A control method according to claim 20,wherein the quality control sample is assayed by a plurality ofanalyzing instruments which are located in different facilities.
 23. Aterminal apparatus according to claim 1, further comprising a sampledistinguisher configured to distinguish the quality control sample andthe assay sample.
 24. A method according to claim 9, further comprisingdistinguishing the quality control sample and the assay sample.
 25. Acontrol apparatus according to claim 17, wherein the report analyzes theassay result of the quality sample assayed by the at least one analyzinginstrument against the average of the assay results of the qualitysample assayed by a plurality of analyzing instruments.
 26. A controlmethod according to claim 20, wherein the report analyzes the assayresult of the quality control sample assayed by the at least oneanalyzing instrument against the average of the assay results of thequality control sample assayed by a plurality of analyzing instruments.